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510(k) K201643

ChoiceSpine Tiger Shark Cervical Spacer System by Choice Spine, LLC — Product Code ODP

K201643 is an FDA 510(k) premarket notification submitted by Choice Spine, LLC for the device "ChoiceSpine Tiger Shark Cervical Spacer System". The FDA issued a decision of Substantially Equivalent on December 22, 2020. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Choice Spine, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2020
Date Received
June 17, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Choice Spine, LLC

  • K223869 — ChoiceSpine Blackhawk Ti Cervical Spacer System (September 14, 2023)
  • K220953 — ChoiceSpine TigerShark™ M, Modular Interbody System (September 13, 2022)
  • K220024 — ChoiceSpine Navigation System (July 6, 2022)
  • K211449 — Triton™ Sacroiliac Joint Fixation System (August 31, 2021)
  • K203311 — ChoiceSpine Blackhawk Ti Cervical Spacer System (May 10, 2021)
  • K203561 — ChoiceSpine Navigation System (January 4, 2021)
  • K191621 — ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody S (August 15, 2019)
  • K191367 — Harrier-SA Lumbar Interbody System (July 5, 2019)
  • K091531 — CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SP (November 2, 2009)

Other clearances for product code ODP

  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)
  • K254105 — Hive™ Standalone Cervical System and Hive™ C Interbody System (February 13, 2026)
  • K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Inte (January 16, 2026)

FDA data resources